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What is an FDA 510k submission?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the devices intended

What is FDA guidance 510 K summary?

A 510(k) is a submission containing information required under 21 CFR 807.87. All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed device, also referred to as a predicate. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.

Can you see 510K submissions?

The FDA maintains a database of premarket notification 510(k) submissions on its official website, enabling users to search for existing submissions using criteria such as the 510(k) number, applicant, device name or FDA product code.

What is included in a 510 K submission?

The documentation must include drawings, schematics, and a description of the devices intended use and performance. Selection of the most appropriate predicate device The 510(k) submission must include a comparison of the device under consideration to a predicate device already on the market.

What does FDA 510k clearance mean?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act).

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